Director Regulatory Intelligence

AstraZeneca • Gaithersburg, MD

18h • Hybrid

About The Position

Are you ready to transform Regulatory Intelligence into actionable insights for product teams? Do you want to work on innovative projects of high importance for our Respiratory and Immunology portfolio? Join us at AstraZeneca, where we are investing in internal capabilities to discover and accelerate the delivery of next-generation respiratory and immunology modalities for patients. As part of the Respiratory & Immunology (R&I) Regulatory Affairs team, you will play a crucial role in bringing these transformative therapies from the lab to life. This role sits at the intersection of competitive insight, regulatory science, and portfolio strategy translating emerging signals into clear choices for our pipeline and marketed assets. The role will be based at AstraZeneca’s dynamic R&D site Gaithersburg, MD. More specifically, you will be part of the Strategy and Innovation Team which comprises a diverse group of individuals including global regulatory strategists, medical writers, labeling, data analytics, and policy and intelligence areas to deliver a breadth of capabilities to support the TA and portfolio.

Requirements

• Advanced degree in a science related field and/or other appropriate knowledge/experience.
• At least 7 years of demonstrated ability in regulatory strategy, intelligence, and/or policy.
• Detailed understanding of US and European regulatory affairs and an understanding of the broader regulatory ecosystem.
• Proficiencies in data impact analysis, strategic thinking, creative problem solving, and excellent oral and written communication skills.
• Ability to evaluate the impact and drive change of key Regulatory Intelligence on disease area and project strategy.
• Ability to discern and communicate relevant Regulatory news to key collaborators and senior leaders
• Solid understanding of Regulatory Intelligence Tools.
• Experience working cross-functionally with diverse stakeholders.
• Experience working in BioPharmaceutical development including but not limited to, pharmaceutical/biotech industry and government.

Nice To Haves

• Solid understanding of the commercial aspects of BioPharmaceutical development
• In-depth knowledge of the R&I therapeutic area
• Broad background of experience working in pharmaceutical business and prior experience in leading competitive intelligence within the pharmaceutical industry or in associated industries
• Critical thinking on current global regulatory science trends and questions with a good understanding of the corresponding scientific and clinical components.
• Previous regulatory policy experience or working with external trade and scientific associations.

Responsibilities

• Provides disease area regulatory intelligence, interpretation, and impact analysis of the emerging external regulatory and competitive landscape to support risk assessment and portfolio decisions.
• Partners closely with senior regulatory leaders and cross-functional intelligence groups to anticipate shifts in guidance and identify precedents that unlock smarter development pathways.
• Helps convert complex data into action that shortens timelines, strengthens labels, and improves patient outcomes.
• Conducts analysis and impact assessment of Regulatory Intelligence across the portfolio (e.g., precedents, relevant guidance, approval summaries) and communicate findings to key stakeholders and senior leaders, including R&I Regulatory Affairs VP, Executive Regulatory Science Directors, and Global Regulatory Leads.
• Collaborates with Regulatory Affairs teams to conduct bespoke regulatory research and provide the Regulatory Intelligence aspect of disease area- and product-specific Regulatory strategies.
• Collaborates with other regulatory intelligence groups within AZ to interpret EMA, FDA, and/or other global Health Authority trends, perspectives, reports, activities, etc.
• Identifies regulatory opportunities for portfolio acceleration, e.g., novel regulatory pathways, opportunities for adoption of novel technology or innovative evidence generation methods.
• Works closely with Clinical Information Science and Commercial Intelligence and other R&I experts to provide regulatory interpretation and analysis to emerging disease area information.
• Liaises with global regulatory policy and drive coordination within R&I to respond to draft Health Authority guidance documents and ensure R&I priorities are reflected in external regulatory policy engagement.
• Collaborates with International, China, and Japan RADs regarding disease area-specific guidance and regulatory intelligence aspects in each region, contributing to overall Regulatory landscape per disease.
• Identifies opportunities and to leverage artificial intelligence and other new tools to simplify business process; drive implementation and adoption of novel technologies to enhance efficiency and facilitate regulatory intelligence activities.

Benefits

• short-term incentive bonus opportunity
• equity-based long-term incentive program
• retirement contribution
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director